NCT03678454已完成不适用
Prospective Registry of Iclusig® (Ponatinib) Used in Clinical Practice for the Treatment of Patients With Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium
Incyte Biosciences Benelux19 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- Prescribed dose of Iclusig® in routine practice in Belgium
研究概览
简要总结
This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with confirmed diagnosis of:
- •CML (chronic, accelerated or blast phase) who is resistant or intolerant to dasatinib or nilotinib; and for whom subsequent treatment with imatinib is not clinically appropriate; or who has the T315I mutation.
- •Ph+ ALL who is resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who has the T315I mutation.
- •Patients on treatment with Iclusig® or prescribed for treatment with Iclusig® during the registry (treatment decisions should be taken outside the registry).
- •Written informed consent obtained from the patient, if still alive (NPP participants that were still on Iclusig® treatment on 01 March 2016, but who died before the start of this registry will be included without informed consent provided that a waiver is granted by the ethics committee for inclusion of these patients).
排除标准
- •Concurrently participating in a clinical study, at any time during the registry period, in which the patient is exposed to Iclusig® or to another investigational product/ vaccine (pharmaceutical product/ device).
结局指标
主要结局
Prescribed dose of Iclusig® in routine practice in Belgium
时间窗: Up to 3 years
Prescribed dose of Iclusig® in milligrams.
次要结局
- Estimate of additional health care utilization cost(Up to 3 years)
- Overall clinical benefit rate of Iclusig® based on response criteria for CML or Ph+ ALL in Belgium(Up to 3 years)
研究者
研究点 (19)
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